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Surgical procedures for glaucoma aim to reduce intraocular pressure (IOP) resulting from impaired aqueous humor drainage in the trabecular meshwork and/or Schlemm’s canal. In the primary (conventional) outflow pathway from the eye, aqueous humor passes through the trabecular meshwork, enters a space lined with endothelial cells (Schlemm’s canal), drains into collector channels, and then into the aqueous veins. Increases in resistance in the trabecular meshwork and/or the inner wall of Schlemm’s canal can disrupt the balance of aqueous humor inflow and outflow, resulting in an increase in IOP and glaucoma risk.

Surgical intervention may be indicated in patients with glaucoma when the target IOP cannot be reached pharmacologically. Trabeculectomy (guarded filtration surgery) is the most established surgical procedure for glaucoma, allowing aqueous humor to directly enter the subconjunctival space. This procedure creates a subconjunctival reservoir with a filtering “bleb” on the eye, which can effectively reduce IOP, but is associated with numerous and sometimes sight-threatening complications (e.g., leaks, hypotony, choroidal effusions and hemorrhages, hyphemas or bleb-related endophthalmitis) and long-term failure. Other surgical procedures (not addressed in this policy) include trabecular laser ablation and deep sclerectomy, which removes the outer wall of Schlemm’s canal and excises deep sclera and peripheral cornea.

More recently the Trabectome™, an electrocautery device with irrigation and aspiration, has been used to selectively ablate the trabecular meshwork and inner wall of Schlemm’s canal without external access or creation of a subconjunctival bleb. IOP with this ab interno procedure is typically higher than the pressure achieved with standard filtering trabeculectomy. Aqueous shunts may also be placed to facilitate drainage of aqueous humor. Complications of anterior chamber shunts include corneal endothelial failure and erosion of the overlying conjunctiva.

Alternative nonpenetrating methods that are being evaluated for glaucoma are viscocanalostomy and canaloplasty. Viscocanalostomy is a variant of deep sclerectomy and unroofs and dilates Schlemm’s canal without penetrating the trabecular meshwork or anterior chamber. A high-viscosity viscoelastic solution, such as sodium hyaluronate, is used to open the canal and create a passage from the canal to a scleral reservoir. It has been proposed that viscocanalostomy may lower IOP while avoiding bleb-related complications.

Canaloplasty was developed from viscocanalostomy and involves dilation and tension of Schlemm’s canal with a suture loop between the inner wall of the canal and the trabecular meshwork. This ab externo procedure uses the iTrack™ illuminated microcatheter (iScience Interventional) to access and dilate the length of Schlemm’s canal and to pass the suture loop through the canal. An important difference between viscocanalostomy and canaloplasty is that canaloplasty attempts to open the entire length of Schlemm’s canal, rather than one section of it.

Since aqueous humor outflow is pressure-dependent, the pressure in the reservoir and venous system is critical for reaching the target IOP. Therefore, some procedures may not be able to reduce IOP below the pressure of the distal outflow system used, e.g., below 15 mm Hg, and are not indicated for patients for whom very low IOP is desired (e.g., those with advanced glaucoma). Health outcomes of interest are the IOP achieved, reduction in medications, ability to convert to trabeculectomy if the procedure is unsuccessful, complications, and durability of the procedure.

The iTrack (iScience Interventional) received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) in 2004 as a surgical ophthalmic microcannula that is indicated for the general purpose of “fluid infusion and aspiration, as well as illumination, during surgery.” In 2008, the iTrack received FDA-clearance for the indication of “catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open angle glaucoma.”

Related medical policies are Ophthalmologic Techniques of Evaluating Glaucoma and Aqueous Shunts and Devices for Glaucoma.

• Medical therapy has failed to adequately control intraocular pressure, AND
• The patient is not a candidate for any other intraocular pressure lowering procedure (e.g. trabeculectomy or glaucoma drainage implant) due to a high risk for complications.

Canaloplasty is considered investigational under all other conditions, including angle-closure glaucoma.

Viscocanalostomy is considered investigational.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

11/30/2012: Policy reviewed; no changes.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.  

Covered Codes

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